Senior Clinical Research Associate - Moscow, Russia
Dear reader, as the Russian government has introduced the Data Protection Law we are obliged to initialy store private documents on Russia located servers. Because of that we kindly ask you to apply for this position on HH.RU website. Thank you for understanding,
We are currently looking for talented Clinical Research Associates for our Sponsor based positions in Moscow. If you have enough knowledge and experience we are willing to hire you or promote to a Senior CRA or CRA I/II. Our sponsors are big pharma companies so you can be sure of working only with international trials and high standards. We are proud to have an outstanding team of the best professionals on the market and are looking for people who are ready to show great performance and interest in Clinical Trials. As a Clinical Research Associate you will manage all aspects of study site monitoring according to Covance SOP, GCP, and ICH guidelines, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.
You will become a part of our team who is always ready to help. You will have a possibility to devote all your professional skills and knowledge into monitoring investigational sites as we organize our work environment and responsibilities with high standards.
Our sponsor invests heavily in training and creates modern system of Clinical Trials so if you are interested in working with a great team and expand your horizons feel free to reach us. Our recruiter, Krzysztof Orzechowski, is available to speak with you on ****** or LinkedIn.
- All aspects of site management as prescribed in the project plans
- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks
- Negotiation of study budgets with potential investigators and collaboration with Covance legal department with statements of agreements
- Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.
- Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems
- Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
- Excellent understanding of Serious Adverse Event (SAE) reporting
- Ability to resolve project-related problems and prioritize workload for self and team
- You must have previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits).
- Educational background in life sciences
This job was originally posted as www.emedcareers.com/job/960521396